An Open, Single-Center,Single Arm Trial to Evaluate the Efficacy and Safety of Increased Dose of Icotinib in Advanced None Small Cell Lung Cancer Patients After Routine Gefitinib Therapy
This single center, single arm open label study is designed to assess the safety and
efficacy of using high dose of Icotinib (Conmana) as a way to treat patients with non-small
cell lung cancer that progressed after routine gefitinib therapy by progression-free
survival, as well as overall survival and disease control rate. The adverse events and
adverse reaction are evaluated as well.
- Histologically or cytologically confirmed local advanced or metastatic stage IIIB/IV
- Have been treated with gefitinib and achieved completed response, partial remission,
or stable disease within 3 months after first dose of gefitinib.
- At least one measurable lesion according to Response Evaluation Criteria in Solid
- Signed and dated informed consent before the start of specific protocol procedures.
- Allergic to icotinib.
- Gefitinib excepted, experience of Anti-tumor Monoclonal Antibody or small molecular
compounds therapy such as erlotinib or Cetuximab.
- Severe systemic disease out of control such as unstable or uncompensated
Type of Study:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival is defined as a duration from the date that first dose is given to disease progression or death.
Outcome Time Frame:
Hu Chengping, M.D.
Xiangya Hospital, Central-South Univercity
China: Food and Drug Administration
- Non-Small Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms
- Small Cell Lung Carcinoma